Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
G9900285
Study information
Scientific title
Acronym
Study hypothesis
1. Treatment trial: to test the hypothesis that continuous use of simple analgesia in osteoarthritis (OA) knee is more effective in reducing pain in the affected joint than analgesia used on an 'as required' basis.
2. Adherence trial: to test the hypothesis that a simple intervention delivered by practice nurses can increase adherence to continuous analgesia.
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Osteoarthritis of the knee
Intervention
Treatment trial:
1. Continuous use paracetamol (4 g daily)
2. 'As required' paracetamol (up to 4 g daily as needed)
Adherence trial (all patients in treatment group 1):
1. Individualised educational intervention to promote adherence delivered by practice nurse
2. No intervention
Intervention type
Drug
Phase
Not Specified
Drug names
Paracetamol
Primary outcome measure
Treatment trial: pain in the affected joint measured by 100 mm visual analogue scale
Adherence trial: Proportion of patients who adhere to the regimen for continuous paracetamol
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/09/1999
Overall trial end date
01/03/2002
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Male and female patients over 55 years
2. Clinical diagnosis osteoarthritis of the knee
3. Current joint pain score greater than 30 on a 10 mm visual analogue scale
Participant type
Patient
Age group
Senior
Gender
Both
Target number of participants
244 - Discontinued after March 2002
Participant exclusion criteria
1. Serious concomitant illness
2. Other pain-related conditions
3. Abnormal liver function tests
4. History of analgesic abuse or overdose
5. Severe OA awaiting joint replacement
6. Psychological disorders requiring treatment
7. Patients unable to follow instructions/complete questionnaires.
8. Use of over the counter medication containing paracetamol for duration of the study
Recruitment start date
01/09/1999
Recruitment end date
01/03/2002
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Academic Rheumatology
Nottingham
NG5 1PB
United Kingdom
Sponsor information
Organisation
Medical Research Council (MRC) (UK)
Sponsor details
20 Park Crescent
London
W1B 1AL
United Kingdom
+44 (0)20 7636 5422
clinical.trial@headoffice.mrc.ac.uk
Sponsor type
Research council
Website
Funders
Funder type
Research council
Funder name
Medical Research Council (MRC) (UK)
Alternative name(s)
MRC
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
Trial not published due to insufficient number of participants